Regulatory and Site Start Up Specialist

About the Role: Precision for Medicine is a Clinical Research Organization seeking a Regulatory and Start Up Specialist. You will be responsible for the timely and quality delivery of site activation readiness within Australia, foreseeing and mitigating risks while ensuring compliance with international and local regulations.

What You'll Do

• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities (CA) and Ethics Committees (EC).
• Maintain project plans, trackers, and regulatory intelligence tools.
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms.
• Act as the Subject Matter Expert for site-level critical path data points, securing on-time site activation.
• Review and manage the collection of essential documents required for site activation and IMP release.

What You Bring

• Bachelor's degree in life sciences, healthcare, or a Registered Nurse (RN) qualification.
• 1+ years of experience as a Regulatory or Site Start-Up specialist in a CRO, pharmaceutical, or biotech industry.
• Strong communication and organizational skills, with fluency in English.
• Bonus: Experience with milestone tracking tools, contract negotiations, and a pharmacy qualification.

Benefits

• Opportunity to work across oncology and rare disease therapeutic areas.
• Collaborative environment valuing employee contributions and ideas.
• Fully remote work flexibility within Australia.